Quality Assurance Manager

Position Summary: Ensures compliance with all US and International Quality requirements including participation in all agency audits. The QA Manager oversees all Quality Assurance functions.Responsible for the oversight of all Quality Assurance day to day functions in manufacturing, packaging, and warehouse operations. Works with Quality ManagerDirector and leads to ensure adherence to GMP processes and company procedures. Proposes and implements procedure updates new procedures as needed to ensure GMP compliance. Works closely with Quality Control Lab and Operations to ensure timely dispositions of deviations, investigations, and change control proposals. Position Scope: Manages Quality Assurance Leads, QA Inspectors, Label Room AttendantPosition Responsibility: Enforces the Standard Operating Procedures (SOP's) that are applicable to Production (Manufacturing and Packaging) Distribution, Regulatory, R&D, and Quality Departments. Reviews, edits, and drafts department SOPs to ensure continued compliance with applicable regulations.Oversight of Quality sampling processes of raw materials, in-process products, labels, and finished goods. Ensures raw materials, bulk goods and finished products are released in a timely manner to ensure service level.Assures compliance by following Food and Drug Administration's Good Manufacturing Practices as well as other regulatory standards as required by the department.Assists with all audits of Country Life as needed (FDA, NSF, etc.)Performs and reviews audits of suppliers, whether in-person or digital. Performs internal audits as per procedure requirements. Reports findings to cross-functional team to identify areas for improvement. Oversight of mock recall process.Responsible for halting a process once it is found to be a deviation of the SOP. Ensures deviations are issued as required and sends status notices in a timely manner in order to control of all non-conforming material. Tracks the deviations to ensure proper completion of relevant documentation prior to release of product. Summarizes and trends the deviations consistent with cGMP requirements.Ensures that appropriate documentation is reviewed for completeness in files, batch records, and packaging work orders as required, e.g. deviations, investigationhold municates, orally and written, with other departments both internally and externally to provide status updates, e.g., Purchasing, Distribution. Communicates with the Purchasing department and outside vendors to obtain paperwork needed for product release.Provides technical assistance as necessary to ensure that products meet all required specifications.Attends inventory planning meetings to advise Production regarding status of materials and to obtain production requirements for ensuing time period. Trains additional personnel in tasks and duties in the release area and to ensure coverage as necessary.Human Resource functions to include subordinate performance reviews, recommending promotions, issuing disciplinary warnings, time clock administration, as well as work shift assignment scheduling.Maintains professional and technical knowledge by attending educational symposia; reviewing professional publications; establishing personal networks; participating in professional societies, etc.The above is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.QUALIFICATIONSExperience and Skills:8-10 years prior experience in a Quality Assurance Department in the area of pharmaceuticals or Natural Products including at least 2 years prior SupervisoryManagerial experience. Must have strong problem-solving skills and be able to assist the team when quality issues arise.Demonstrated ability to work well on cross-functional teams with project management skills.Proven strong written and oral skills, together with strong organizational and management skills are a must.Ability to train employees, both inter- and intra-departmentallyStrong competence in office software applications including Excel, Word, Outlook (Power Point a plus) and mainframe experience. Education and Certifications:Bachelor's degree, preferably in management or a food and supplement related field

Created: 2024-11-06